End points of clinical trials in metastatic castration-resistant prostate cancer: A systematic review

Table 3 Characteristics of randomized clinical trials including time-to-event measures as the primary end point after first-line medical treatment of metastatic castration-resistant prostate cancer

Trial	Arms	No. pts	Publication year	End point	Result(mo)
DAPROCA 9002[26]	ESM	61	1997	TTSP	2.2
	Placebo	68			5.0
EORTC[27]	FLT	100	2001	TTP	2.3
	PDN	101			3.4
USOR[28]	MXN + PDN	56	2002	TTTF	8.11
	PDN	63			4.1
Vinorelbine Trial[29]	VNR + HDC	206	2004	PFS	3.71
	HDC	208			2.8
UCSF[30]	SIP-T	82	2006	TTP	11.7
	Placebo	45			10.0
Atrasentan Trial[31]	ATR	408	2007	TTP	HR = 0.89
	Placebo	401
PROSTVAC[32]	PROSTVAC	82	2010	PFS	3.8
	Placebo	40			3.7
PROSTY Trial[33]	DOC three-weekly	184	2013	TTTF	4.9
	DOC two-weekly	177			5.61

¹Statistically significant difference. ATR: Atrasentan; DOC: Docetaxel; ESM: Estramustine; FLT: Flutamide; HDC: Hydrocortisone; HR: Hazard ratio; MXN: Mitoxantrone; PDN: Prednisone; PFS: Progression-free survival; PROSTVAC: Vaccinia-PSA-TRICOM and Fowlpoc-PSA-TRICOM; SIP-T: Sipuleucel-T; TTP: Time to progression; TTSP: Time to subjective progression; TTTF: Time to treatment failure; VNR: Vinorelbine.